The Recall Desk
HighFDA (Devices)·Z-1832-2012·Announced 2012-06-27

Terumo Recalls Sarns High-Flow Aortic Arch Cannula Due to Foreign Substance

Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannulas because a foreign substance found on connectors can be dislodged during use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a Class II medical device with a risk of harm (foreign substance dislodgement) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling 133,793 units of the Sarns High-Flow Aortic Arch Cannula (5.2 mm, 16 Fr). The device is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. The recall covers specific catalog and lot codes distributed nationwide in the United States and in various international markets.

During the production of one lot, Terumo CVS identified a foreign substance on the outer surface of some cannulae connectors. A preliminary investigation determined that the substance was likely deposited during the molding process and can be dislodged from the cannula surface. The exact composition of the particles has not been fully determined in the provided text.

Healthcare facilities and distributors should stop using the affected devices and contact Terumo CVS for further instructions. Consumers should not use these medical devices if they have them in their possession.

The recalled product

Product
SARNS HIGH-FLOW AORTIC ARCH CANNULA: 5.2 MM (16 FR) 00 WITH 3/8" CONNECTOR, 7.5" (19 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Cardiovascular
Hazard
Affected units
133,793

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Catalog number: 12315 and Lot codes: 0552019
  • 0557299
  • 0562142
  • 0572238
  • 0575869
  • 0579315
  • 0584831
  • 0590890
  • 0594622
  • 0598430
  • 0604045
  • 0612256
  • 0625339
  • 0640189
  • 0646473
  • 0652905
  • 0656574
  • 0666574
  • 0671713
  • and 593606C.

Distribution

Distributed nationwide across the United States.

The notice also names 44 states specifically:

Part of a larger recall action

This product is one of 11 recalled by Terumo Cardiovascular Systems Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

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Same manufacturer · Terumo Cardiovascular Systems Corporation

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Same hazard · foreign substance

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